Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: A novel once-monthly, long-acting formulation of an atypical antipsychotic

Clinical Pharmacokinetics

Volumn 48, Issue 9, 2009, Pages 585-600

  Samtani, Mahesh N ^a   Vermeulen, An ^b   Stuyckens, Kim ^b  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b JANSSEN RESEARCH FOUNDATION   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; DIAZEPAM; IBUPROFEN; LORAZEPAM; NONSTEROID ANTIINFLAMMATORY AGENT; OLANZAPINE; PALIPERIDONE; PALIPERIDONE PALMITATE; PARACETAMOL; UNCLASSIFIED DRUG;

ARTICLE; BODY MASS; CLINICAL TRIAL; COMPUTER PROGRAM; CREATININE CLEARANCE; DELTOID MUSCLE; DISTRIBUTION VOLUME; DOSE TIME EFFECT RELATION; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG FORMULATION; DRUG HALF LIFE; GLUTEUS MAXIMUS MUSCLE; HUMAN; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SCHIZOPHRENIA; SEX DIFFERENCE; VARIANCE;

ADOLESCENT; ADULT; AGED; ANTIPSYCHOTIC AGENTS; BAYES THEOREM; CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DATA COLLECTION; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; HUMANS; INJECTIONS, INTRAMUSCULAR; ISOXAZOLES; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; PYRIMIDINES; RETROSPECTIVE STUDIES; SCHIZOPHRENIA; YOUNG ADULT;

EID: 69849099693     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11316870-000000000-00000     Document Type: Article

References (34)

1. Keith SJ, Pani L, Nick B, et al. Practical application of pharmacotherapy with long-acting risperidone for patients with schizophrenia. Psychiatr Serv 2004 Sep; 55 (9): 997-1005
2. Jannes C, van Schaick EA, De Smedt G. A single intramuscular injection of a 9-hydroxy-risperidone palmitate depot preparation to subjects with schizophrenia: a pilot trial for pharmacokinetic and safety evaluation. Raritan (NJ): Johnson & Johnson Pharmacuetical Research & Development, LLC, 1999. (Data on file)
3. Olfson M, Mechanic D, Hansell S, et al. Predicting medication noncompliance after hospital discharge among patients with schizophrenia. Psychiatr Serv 2000 Feb; 51 (2): 216-22
4. Keith SJ, Kane JM. Partial compliance and patient consequences in schizo-phrenia: our patients can do better. J Clin Psychiatry 2003 Nov; 64(11): 1308-15
5. Valenstein M, Copeland LA, Blow FC, et al. Pharmacy data identify poorly adherent patients with schizophrenia at increased risk for admission. Med Care 2002 Aug; 40 (8): 630-9
6. Ascher-Svanum H, Faries DE, Zhu B, et al. Medication adherence and long-term functional outcomes in the treatment of schizophrenia in usual care. J Clin Psychiatry 2006 Mar; 67 (3): 453-60
7. Revill P, Serradell N, Bolos J. Paliperidone. Drugs Future 2006; 31 (7): 579-84
8. Ortho-McNeil-Janssen Pharmaceuticals, Inc. FDA approves Invega® Sustenna™ for the acute and maintenance treatment of schizophrenia [media release]. 2009 Jul 31 [online]. Available from URL: http://www. janssen. com/janssen/news-release. html?item=073109-1 [Accessed 2009 Aug 13]
9. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Invega® (paliperidone) extended-release tablets: US prescribing information [online]. Available from URL: http://www. invega. com/invega/shared/pi/invega. pdf#zoom=100 [Accessed 2009 Aug 13]
10. Johnson & Johnson Pharmaceutical Research & Development, LLC [J&JPRD]. Clinical study report. Open-label, parallel, randomized, dose proportionality, pharmacokinetic study of paliperidone after intramsuclar injection of paliperidone palmitate in the deltoid or gluteal muscle in subjects with schizophrenia. Raritan (NJ): J&JPRD, 2007. (Data on file)
11. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th edition, text revision [DSM-IV-TR]. Arlington (VA): American Psychiatric Association, 2000 Jul
12. DeMeulder M, RemmerieBM, deVries R, etal. Validated LC-MS/MS methods for the determination of risperidone and the enantiomers of 9-hydroxyris-peridone in human plasma and urine. J Chromatogr 2008 Jul 1; 870 (1): 8-16
13. Beal SL, Sheiner LB. NONMEM® users guides. Ellicott City (MD): Icon Development Solutions, 1989-98
14. Mould DR, Baumann A, Kuhlmann J, et al. Population pharmacokinetics- pharmacodynamics of alemtuzumab (Campath) in patients with chronic lymphocytic leukaemia and its link to treatment response. Br J Clin Pharmacol 2007 Sep; 64 (3): 278-91
15. Johnson & Johnson Pharmaceutical Research & Development, LLC [J&JPRD]. Clinical study report. Disposition of paliperidone enantiomers after treatment with different formulations of the racemate and the separate enantioners and the determination of the absolute bioavailability of IR and ER OROS paliperidone. Raritan (NJ): J&JPRD, 2005. (Data on file)
16. Hirano K, YamadaH. Studies on the absorption of practically water-insoluble drugs following injection: IV. An approach for predicting relative intramuscular absorption rates of a drug in oily solution, aqueous suspension and aqueous surfactant solution in rats. Chem Pharm Bull 1981 May; 29 (5): 1410-5
17. Hirano K, Yamada H. Studies on the absorption of practically water-insoluble drugs following injection: VIII. Comparison of the subcutaneous absorption rates from aqueous suspensions in the mouse, rat, and rabbit. J Pharm Sci 1983 Jun; 72 (6): 608-12
18. Zuidema J, Kadir F, Titulear HAC, et al. Release and absorption rate of intramuscularly and subcutaneously injected pharmaceuticals (II). Int J Pharm 1994; 105 (3): 189-207
19. Johnson & Johnson Pharmaceutical Research & Development, LLC [J&JPRD]. ER OROS paliperidone: summary of clinical pharmacology studies. Raritan (NJ): J&JPRD, 2005. (Data on file)
20. Johnson & Johnson Pharmaceutical Research & Development, LLC [J&JPRD]. Risperidone: summary of clinical pharmacology studies. Raritan (NJ): J&JPRD, 2006. (Data on file)
21. Bouzom F, Laveille C, Merdjan H, et al. Use of nonlinear mixed effect mod-eling for the meta-analysis of preclinical pharmacokinetic data: application to S 20342 in the rat. J Pharm Sci 2000 May; 89 (5): 603-13
22. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharm Biopharm 1981 Aug; 9 (4): 503-12
23. Bruno R, Vivier N, Vergniol JC, et al. A population pharmacokinetic model for docetaxel (Taxotere): model building and validation. J Pharmacokinet Biopharm 1996 Apr; 24 (2): 153-72
24. Preston SL, Drusano GL, Berman AL, et al. Levofloxacin population pharma-cokinetics and creation of a demographic model for prediction of individual drug clearance in patients with serious community-acquired infection. Anti-microb Agents Chemother 1998 May; 42 (5): 1098-104
25. Samtani MN, Lohle M, Grant A, et al. Betamethasone pharmacokinetics after two prodrug formulations in sheep: implications for antenatal corticosteroid use. Drug Metab Dispos 2005 Aug; 33 (8): 1124-30
26. Holford NH, Ambros RJ, Stoeckel K. Models for describing absorption rate and estimating extent of bioavailability: application to cefetamet pivoxil. J Pharmacokinet Biopharm 1992 Oct; 20 (5): 421-42
27. Wahlby U, Jonsson EN, Karlsson MO. Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis. AAPS PharmSci 2002; 4 (4): E27
28. Lee A, Cooper MG, Craig JC, et al. Effects of nonsteroidal anti-inflammatory drugs on postoperative renal function in adults with normal renal function. Cochrane Database Syst Rev 2007; (2): CD002765
29. Duffull SB, Aarons L. Development of a sequential linked pharmacokinetic and pharmacodynamic simulation model for ivabradine in healthy volunteers. Eur J Pharm Sci 2000; 10 (4): 275-84
30. Cleton A, Rossenu S, Hough D, et al. Assessment of the dose proportionality of paliperidone palmitate 25, 50, 100 and 150 mg eq., a new long-acting injectable antipsychotic following administration in the deltoid or gluteal muscles [abstract PI-74]. Clin Pharmacol Ther 2008; 83 Suppl. 1: S31 [online]. Available from URL: http://www. nature. com/clpt/journal/v83/n1s/pdf/ clpt 200838a. pdf [Accessed 2009 Jul 14]
31. Reynolds LM, Infosino A, Brown R, et al. Pharmacokinetics of rapacuronium in infants and children with intravenous and intramuscular administration. Anesthesiology 2000 Feb; 92 (2): 376-86
32. Cleton A, Rossenu S, Hough D, et al. Evaluation of the pharmacokinetic profile of gluteal versus deltoid intramuscular injections of paliperidone palmitate 100mg equivalent in patients with schizophrenia [abstract PI-75]. Clin Pharmacol Ther 2008; 83 Suppl. 1: S31 [online]. Available from URL: http://www. nature. com/clpt/journal/v83/n1s/pdf/clpt200838a. pdf [Accessed 2009 Jul 14]
33. Cockshott WP, Thompson GT, Howlett LJ, et al. Intramuscular or intra-lipomatous injections? N Engl J Med 1982 Aug 5; 307 (6): 356-8
34. Haramati N, Lorans R, Lutwin M, et al. Injection granulomas: intramuscle or intrafat? Arch Fam Med 1994 Feb; 3 (2): 146-8